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Title: RIMS Tech Lead/Architect
Location: Remote – US
Client: Biogen
Individual with Pharmaceutical Regulatory Information Management Domain experience (submission, publishing, etc.), the individual will have to work and manage the technical SDLC deliverables with an external vendor on SaaS application upgrade to next version where coupe of integration points will be impacted, the person should be able to understand the all the application components how those were connected/integrated, Aws/Azure AD, OKTA, work with a business analyst on defining data governance, business process, defining various architecture components, drafting architecture presentation and document.
Job Description:
Drive technical discussion related to the various technologies related to clinical R&D applications
Define, author, and present various architecture footprints i.e. Business, Logical, Integration, Security, Infrastructure, etc.
Adhere to Biogen SDLC methodology/process on authoring various technical deliverables
Attention to detail and provide detailed documentation required in a 21 CFR validated environment
Work with vendors and resources, to ensure vendor following SDLC process and deliverables
Support project manager in software updates-specifically with best software implementation practices
Responsible for all technical delivery that includes scheduling meetings with required individuals/group
Active participation in various meetings providing technical thought process
Create support transition-related documents
Provide daily/weekly updates to the platform owner
Any other activity/task assigned by the platform owner and/or project lead/manager
Required Skills but not limited to:
Individual with 60-70% technical and 40-30% domain experience in R&D area in pharma/biotech industry
Understanding on research, regulatory compliance, biometrics, and clinical system
Strong experience with data architecture and application architecture and knowledge about secure transmissions, digital certificates.
Knowledge of Identity and Access Management protocols and technologies: OAuth, OpenID Connect, SAML, Federation, SSO such as OKTA.
Expertise in Azure and AWS cloud-native services
Experience in various architectures and protocols: SOA, REST, XML, sFTP, MFT, WSDL, and SOAP.
Knowledge of API gateway and integrations
Technical documentation, SDLC of GxP applications
Understanding of network architecture, VPN, MPLS, Cloud to On-Prem network
Oracle, Postgres database with strong Unix/Linux skillsets
Storage configuration and sync between cloud accounts
Link: Apply with Resume at Jobboard
Thanks and Regards,
Vinay Bhaskar Nadigatlla
Aqua Information Systems Inc. 300 N Pottstown Pike, Suite # 130 Exton, PA 19341 Contact No:
302-200-0939 Fax:
215-600-1617 Email:
vnadi...@aquainsys.com GTalk:
vnadi...@aquainsys.com